Accès ouvert
2025
article
OpenAlex
Kelvin Cooper, Kanneganti G. K. Murthy, Thomas Balzer, Steve Parkinson et autres
ABSTRACT Lakewood-Amedex Biotherapeutics Inc. has developed a new class of antimicrobials called the Bisphosphocin class, with Nu-3 as a leading candidate, which is currently in clinical development for treating mildly infected diabetic foot ulcers (iDFUs). Nu-3 acts through a novel mechanism of …
2024
article
OpenAlex
Janina Boyken, Jessica Lohrke, Axel Treu, Joerg Neddens et autres
Background The presence of gadolinium traces in the skin after administration of gadolinium-based contrast agents (GBCAs) raised safety concerns regarding a potential association with small fiber neuropathy (SFN). Purpose To investigate signs of SFN in rat foot pads by quantification of the …
de
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2020
letter
OpenAlex
Chia‐Ying Liu, Laura Schöckel, Pamela Habib, Thomas Balzer et autres
us, de
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2020
book
OpenAlex
Thomas Balzer, Erhard Buchberger
Die Datenschutzgrundverordnung (DSGVO) hat auch in rechts- und steuerberatenden Berufen beispiellos neu mobilisiert. Das Zeitalter der Digitalisierung, die ungebremst sensible Daten produziert, rückt dabei auch den Datenschutz als Personenschutz immer stärker in den Blick. So ist die Umsetzung der für hohe Bußgelder …
Accès ouvert
2019
article
OpenAlex
Laura Schöckel, Thomas Balzer, Hubertus Pietsch
BACKGROUND: Numerous clinical MRI studies have been published that describe an association between the repeated administration of (linear) gadolinium-based contrast agents and increased signal intensity in certain brain areas. In November 2017, the European Commission suspended the use of some of these …
de, us
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Accès ouvert
2018
article
OpenAlex
Jan Endrikat, Susan Dohanish, Nicolas Schleyer, Susanne Schwenke et autres
OBJECTIVES: The aim of this study was to critically assess the evaluation and categorization process for nephrogenic systemic fibrosis (NSF) based on reports received by Bayer from 2006 to 2016. MATERIALS AND METHODS: A total of 779 NSF reports received by Bayer …
de, us
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2017
article
OpenAlex
Cornelia Harz, Laura Schöckel, Jan Endrikat, Hubertus Pietsch et autres
de, us
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Accès ouvert
2016
article
OpenAlex
Henrik Jakob Michaely, Manuela Aschauer, Hannes Deutschmann, Georg M. Bongartz et autres
OBJECTIVE: The aim of this study was to assess the potential risk of gadobutrol-enhanced magnetic resonance imaging (MRI) in patients with moderate to severe renal impairment for the development of nephrogenic systemic fibrosis (NSF). MATERIALS AND METHODS: We performed a prospective, international, …
de, it, at, us, ch, ca
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Accès ouvert
2016
article
OpenAlex
Jan Endrikat, Kai Vogtlaender, Susan Dohanish, Thomas Balzer et autres
OBJECTIVE: The aim of this study was to provide a systematic safety analysis of gadobutrol after more than 29 million applications in clinical routine. MATERIALS AND METHODS: Forty-two clinical development phase II to IV studies on gadobutrol or comparator and the postmarketing …
de
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2016
article
OpenAlex
Thomas Balzer, Michael Nugel
Accès ouvert
2015
article
OpenAlex
Jacob M. Agris, Hubertus Pietsch, Thomas Balzer
KEY POINTS : The study by Stojanov et al does not convincingly support the conclusion that gadobutrol causes higher T1 enhancement in brain on unenhanced MRI. The study by Stojanov et al does not rule out confounding factors . The study by …
us
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Accès ouvert
2015
article
OpenAlex
Jan Endrikat, Susan Dohanish, Thomas Balzer, Josy Breuer
PURPOSE: To summarize the safety data of gadoxetate disodium, reported in 12 Phase II and III clinical development studies and in the postmarketing surveillance database. MATERIALS AND METHODS: Patients with liver lesions received gadoxetate disodium-enhanced liver magnetic resonance imaging (MRI). Adverse events …
de, us
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